Shoulder SurgeryNCT04769570
Effect of Interscalene and Suprascapular Nerve Block on Analgesia Consumption After Adhesive Capsulitis Surgery
A study testing interscalene brachial plexus block and suprascapular nerve block in people with Shoulder Surgery, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
In this study, a combination of different types of blocks for adhesive capsulitis surgery, the investigators will investigate the impact on patient satisfaction and analgesic consumption after surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Surgery
- What is being tested?
- interscalene brachial plexus block and suprascapular nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Feb 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I- ASA II Patients
Who cannot join
- history of allergy to the study medication
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
In this study, a combination of different types of blocks for adhesive capsulitis surgery, the investigators will investigate the impact on patient satisfaction and analgesic consumption after surgery.
Read the detailed description
General anesthesia will be performed in all patients for arthroscopic adhesive capsulitis shoulder surgeries. In the first group of patients (Group IPSB), interscalene brachial plexus block will be applied 30 minutes before surgery, while interscalene brachial plexus block and suprascapular nerve block (SSNB) administration to the second group patients (Group SSNB) before surgery. Patients in the third group (Group C) will be considered the control group and no block will be performed. Patient-controlled analgesia (PCA) with morphine will be used in all three groups for postoperative analgesia. Preoperative hemodynamic data of patients, postoperative pain scores (VAS), morphine consumption, patient satisfaction score, requirement of additional analgesia and observed side effects were recorded. Consumption of analgesia 24 hours after surgery and patient satisfaction will be evaluated.
- Conditions
- Shoulder Surgery
- Being tested
- interscalene brachial plexus block, suprascapular nerve block, Group Control
- Keywords
- suprascapular nerve block, interscalene brachial plexus block, ultrasound, patient satisfaction score, analgesic consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interscalene brachial plexus blockProcedure or surgery
Single shot ultrasound guided interscalene brachial plexus block will be performed preoperatively to patients.Patient-controlled analgesia (PCA) with morphine will be used for postoperative analgesia.
suprascapular nerve blockProcedure or surgery
Single shot ultrasound guided interscalene brachial plexus block and Suprascapular nerve block will be performed preoperatively to patients.Patient-controlled analgesia (PCA) with morphine will be used for postoperative analgesia.
Group ControlProcedure or surgery
consist of the patient group without any procedure.
| Study group | Role | What they receive |
|---|---|---|
| Group IPSB | Active comparator | In the first group of patients (Group IPSB), ultrasound-guided interscalene brachial plexus block will be applied 30 minutes before surgery. Receives: Procedure: interscalene brachial plexus block |
| Group SSNB | Active comparator | In the second group of patients, ultrasound-guided interscalene brachial plexus block and suprascapular nerve block will be applied 30 minutes before surgery. Receives: Procedure: suprascapular nerve block |
| Group Control | Active comparator | Patients in the third group (Group C), will be considered the control group and no block will be performed. Receives: Procedure: Group Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal Analogue Scores
A research assistant, blinded to the group allocation, interviewed patients and collected data in the 24 hours postoperative period.Verbal Analog Pain Score value will be the lowest 0 and the highest 10. At the highest value, the patient's pain is at its maximum. and whether higher scores mean worse outcome.
Measured: 24 hours after surgery
opioid consumption
In the recovery room all patients will be given a patient-controlled analgesia device containing morphine and 24 hours postoperative period will be recorded.
Measured: 24 hours after surgery
Secondary outcomes (1)
Complications of the procedures
The complications of the intervations will be recorded
Measured: During the blocks and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start22 Feb 2021
- Primary completion29 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Shoulder SurgeryStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Seçkin Pehlivan, TC Erciyes University
- Investigators
- Sibel Pehlivan, MD, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769570
- Sponsor's protocol ID
- 2015/580
- Status last verified
- Jul 2022
- First submitted
- 21 Feb 2021
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De- identified individual participant data for all primary and secondary outcome measures will be made available.
Publications
Bowens C Jr, Sripada R. Regional blockade of the shoulder: approaches and outcomes. Anesthesiol Res Pract. 2012;2012:971963. doi: 10.1155/2012/971963. Epub 2012 Jun 25.
PubMed 22792099Chen HP, Shen SJ, Tsai HI, Kao SC, Yu HP. Effects of Interscalene Nerve Block for Postoperative Pain Management in Patients after Shoulder Surgery. Biomed Res Int. 2015;2015:902745. doi: 10.1155/2015/902745. Epub 2015 Nov 24.
PubMed 26688821Cabaton J, Nove-Josserand L, Mercadal L, Vaudelin T. Analgesic efficacy of ultrasound-guided interscalene block vs. supraclavicular block for ambulatory arthroscopic rotator cuff repair: A randomised noninferiority study. Eur J Anaesthesiol. 2019 Oct;36(10):778-786. doi: 10.1097/EJA.0000000000001065.
PubMed 31361631
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Interscalene and Suprascapular Nerve Block on Analgesia Consumption After Adhesive Capsulitis Surgery
- ClinicalTrials.gov ID
- NCT04769570
- Acronym / sponsor ID
- 2015/580
- Conditions
- Shoulder Surgery
- Keywords
- suprascapular nerve block, interscalene brachial plexus block, ultrasound, patient satisfaction score, analgesic consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 29 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, a combination of different types of blocks for adhesive capsulitis surgery, the investigators will investigate the impact on patient satisfaction and analgesic consumption after surgery.
Detailed description
General anesthesia will be performed in all patients for arthroscopic adhesive capsulitis shoulder surgeries. In the first group of patients (Group IPSB), interscalene brachial plexus block will be applied 30 minutes before surgery, while interscalene brachial plexus block and suprascapular nerve block (SSNB) administration to the second group patients (Group SSNB) before surgery. Patients in the third group (Group C) will be considered the control group and no block will be performed. Patient-controlled analgesia (PCA) with morphine will be used in all three groups for postoperative analgesia. Preoperative hemodynamic data of patients, postoperative pain scores (VAS), morphine consumption, patient satisfaction score, requirement of additional analgesia and observed side effects were recorded. Consumption of analgesia 24 hours after surgery and patient satisfaction will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group IPSB | Active comparator | Procedure: interscalene brachial plexus blockIn the first group of patients (Group IPSB), ultrasound-guided interscalene brachial plexus block will be applied 30 minutes before surgery. |
| Group SSNB | Active comparator | Procedure: suprascapular nerve blockIn the second group of patients, ultrasound-guided interscalene brachial plexus block and suprascapular nerve block will be applied 30 minutes before surgery. |
| Group Control | Active comparator | Procedure: Group ControlPatients in the third group (Group C), will be considered the control group and no block will be performed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I- ASA II Patients
Key exclusion criteria (2 listed)
- history of allergy to the study medication
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interscalene brachial plexus blockSingle shot ultrasound guided interscalene brachial plexus block will be performed preoperatively to patients.Patient-controlled analgesia (PCA) with morphine will be used for postoperative analgesia. | Procedure or surgery | Group IPSB |
| suprascapular nerve blockSingle shot ultrasound guided interscalene brachial plexus block and Suprascapular nerve block will be performed preoperatively to patients.Patient-controlled analgesia (PCA) with morphine will be used for postoperative analgesia. | Procedure or surgery | Group SSNB |
| Group Controlconsist of the patient group without any procedure. | Procedure or surgery | Group Control |
Primary outcome
Verbal Analogue Scores
Time frame: 24 hours after surgery
A research assistant, blinded to the group allocation, interviewed patients and collected data in the 24 hours postoperative period.Verbal Analog Pain Score value will be the lowest 0 and the highest 10. At the highest value, the patient's pain is at its maximum. and whether higher scores mean worse outcome.
opioid consumption
Time frame: 24 hours after surgery
In the recovery room all patients will be given a patient-controlled analgesia device containing morphine and 24 hours postoperative period will be recorded.
1 secondary outcome
Complications of the procedures
Time frame: During the blocks and 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Results publication: PubMed 22792099Bowens C Jr, Sripada R. Regional blockade of the shoulder: approaches and outcomes. Anesthesiol Res Pract. 2012;2012:971963. doi: 10.1155/2012/971963. Epub 2012 Jun 25.
- Results publication: PubMed 26688821Chen HP, Shen SJ, Tsai HI, Kao SC, Yu HP. Effects of Interscalene Nerve Block for Postoperative Pain Management in Patients after Shoulder Surgery. Biomed Res Int. 2015;2015:902745. doi: 10.1155/2015/902745. Epub 2015 Nov 24.
- Results publication: PubMed 31361631Cabaton J, Nove-Josserand L, Mercadal L, Vaudelin T. Analgesic efficacy of ultrasound-guided interscalene block vs. supraclavicular block for ambulatory arthroscopic rotator cuff repair: A randomised noninferiority study. Eur J Anaesthesiol. 2019 Oct;36(10):778-786. doi: 10.1097/EJA.0000000000001065.
- Individual participant dataSharing planned: Yes. De- identified individual participant data for all primary and secondary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sibel Pehlivan, MD principal investigator
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interscalene brachial plexus block and suprascapular nerve block in people with Shoulder Surgery, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal Analogue Scores (time frame: 24 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04769570, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.